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BS ISO 18666:2015

Current
Current

The latest, up-to-date edition.

Traditional Chinese medicine. General requirements of moxibustion devices
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-30-2015

Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Configuration
5 Materials
6 Moxibustion temperature
7 Safety requirements
8 Packaging
9 Labelling
10 Transport and storage
11 Instructions for use (to be provided by the
   manufacturer)
Annex A (informative) - Test methods to determine the
        moxibustion temperature
Annex B (informative) - Method of artificial drying of
        mugwort leaves by heat
Bibliography

Defines the general requirements for configuration, materials, performance and safety requirements of moxibustion devices.

This International Standard specifies the general requirements for configuration, materials, performance and safety requirements of moxibustion devices. It also specifies the minimum requirements for moxibustion materials used in moxibustion devices.

It is applicable across a wide range of moxibustion devices that uses moxa floss as the main combustion material and can remain on or over the body throughout the moxibustion process. It is applicable to moxibustion devices for both single and repeated usage.

This International Standard does not apply to devices that imitate moxibustion, such as electro-moxibustion and infrared moxibustion devices that do not involve the use of moxa floss. It also does not apply to moxa floss used in direct moxibustion.

Committee
CH/100
DevelopmentNote
Supersedes 15/30281262 DC. (11/2015)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 18666:2015 Identical

ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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